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Lymphoma, B-cellPhase 2NCT02592876

Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma

A Phase 2 study testing denintuzumab mafodotin, rituximab and ifosfamide in people with Lymphoma, B-cell and Lymphoma, Large B-Cell, Diffuse, run by Seagen Inc. at 29 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this randomized, open-label study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
denintuzumab mafodotin, rituximab and ifosfamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
29 sitesUnited States
Study dates
Oct 2015to 20 Apr 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL; including de novo and transformed DLBCL) or Grade 3b follicular lymphoma
  • Available representative tissue from the most recent biopsy after the last therapy; if such tissue is not available, a fresh biopsy must be obtained
  • Received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy, and radiotherapy in a limited field or as part of the frontline treatment plan are permitted.
  • Achieved a response of stable disease, partial response, or complete response following the last cycle of frontline treatment. In addition, patients must have relapsed less than or equal to 6 months from the completion of frontline therapy at the time of initial dosing in this clinical trial.
  • Considered eligible for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
  • Fluorodeoxyglucose (FDG)-avid disease by positive emission tomography (PET), and measurable disease greater than 1.5 cm in diameter
  • Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2
  • Adequate kidney and hematologic function assessed from baseline laboratory data

Who cannot join

  • Previous history of indolent lymphoma treated with more than 1 multi-agent chemotherapy regimen or previous cancer therapy for recurrent DLBCL or Grade 3b follicular lymphoma
  • History of autologous or allogeneic stem cell transplant
  • History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year
  • History of progressive multifocal leukoencephalopathy (PML)
  • Cerebral/meningeal disease related to the underlying malignancy that has not been definitively treated
  • Known urinary tract obstruction
  • Patients with the following ocular conditions: corneal disorders, monocular vision (i.e., best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Winship Cancer Institute / Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637-1470

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Shands Cancer Center / University of Florida

    Gainesville, Florida, 32610

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Carbone Cancer Center / University of Wisconsin

    Madison, Wisconsin, United States

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin (Milwaukee)

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • San Antonio Military Medical Center

    San Antonio, Texas, 78234

  • Scripps Mercy Cancer Center

    San Diego, California, 92103

  • Seattle Cancer Care Alliance / University of Washington

    Seattle, Washington, 98109-1023

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • University of Kansas Cancer Center

    Westwood, Kansas, United States

Other trials in United States

About this study

Official title: A Randomized, Open-Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) Plus Rituximab, Ifosfamide, Carboplatin, and Etoposide (19A+RICE) Chemotherapy vs. RICE in the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Who Are Candidates for Autologous Stem Cell Transplant

The purpose of this randomized, open-label study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1 ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or RICE alone. The study will assess whether there is a difference between the 2 groups in the side effects that are reported and the number of patients who achieve complete remission at the end of their study treatment.

Being tested
denintuzumab mafodotin, rituximab, ifosfamide, carboplatin, etoposide
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD19, Autologous Stem Cell Transplant, Drug Therapy, Follicular Lymphoma Grade 3b, Hematologic Diseases, Immune System Diseases, Immunoproliferative Disorders, Immunotherapy, Lymphatic Diseases, Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Monomethylauristatin F, Neoplasms, Neoplasms by Histologic Type, Transformed Lymphoma / DLBCL, Rituximab
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Lymphoma, Follicular, Hematologic Diseases, Immune System Diseases, Immunoproliferative Disorders, Lymphatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • denintuzumab mafodotinDrug

    Also called SGN-CD19A

    Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.

  • rituximabDrug

    375 mg/m^2 by IV infusion, every 3 weeks for up to 3 cycles

  • ifosfamideDrug

    5000 mg/m^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles

  • carboplatinDrug

    AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles

  • etoposideDrug

    100 mg/m^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles

Study groups in NCT02592876
Study groupRoleWhat they receive
19A+RICEExperimentalDenintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide
Receives: Drug: denintuzumab mafodotin; Drug: rituximab; Drug: ifosfamide; Drug: carboplatin; Drug: etoposide
RICEActive comparatorRituximab, ifosfamide, carboplatin, and etoposide
Receives: Drug: rituximab; Drug: ifosfamide; Drug: carboplatin; Drug: etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Remission Rate Per Independent Review Facility

    Number of patients with complete metabolic response by PET (positive emission tomography) and CT (computed tomography) scans, or complete radiologic response by CT only.

    Measured: Up to 4 months

Secondary outcomes (9)

  1. Number of Participants With Adverse Events (AEs)

    Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. AE severity and seriousness are assessed independently. 'Severity' characterizes the intensity of an AE and is graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. An AE is considered 'serious' if it is life-threatening, fatal, requires hospitalization, or is otherwise considered to be medically significant.

    Measured: Up to 4 months

  2. Number of Participants With Laboratory Abnormalities

    Number of participants who experienced a maximum post-baseline laboratory toxicity of Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03).

    Measured: Up to 4 months

  3. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients with complete remission (CR) or partial remission (PR) per independent review facility (IRF) at the end of treatment.

    Measured: Up to 4 months

  4. Duration of Complete Response (CR)

    Defined as the time from the start of the first radiographic documentation of CR per investigator to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

    Measured: Up to 27.9 months

  5. Duration of Objective Response (OR)

    Duration of OR is defined as the time from the start of the first radiographic documentation of OR per investigator to the first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

    Measured: Up to 27.9 months

  6. Progression-free Survival (PFS)

    PFS is defined as the time from randomization to first documentation of disease progression per investigator, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

    Measured: Up to 30 months

  7. Overall Survival (OS)

    OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive.

    Measured: Up to 30 months

  8. Number of Patients Achieving Peripheral Blood Stem Cell (PBSC) Mobilization

    Defined as the number of patients who are able to adequately mobilize PBSC per investigator assessment on or after completion of study treatment, prior to subsequent anticancer therapy.

    Measured: Up to 30 months

  9. Number of Patients Receiving Autologous Stem Cell Transplant (ASCT)

    Number of patients receiving ASCT after completion of study treatment (EOT), prior to subsequent anticancer therapy.

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion20 Apr 2018
  4. Study completion20 Apr 2018

Why it stopped: Sponsor decision based on portfolio prioritization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592876
Sponsor's protocol ID
SGN19A-003
Status last verified
Apr 2019
First submitted
29 Oct 2015
Last updated
17 May 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing denintuzumab mafodotin, rituximab and ifosfamide in people with Lymphoma, B-cell and Lymphoma, Large B-Cell, Diffuse, run by Seagen Inc. at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Remission Rate Per Independent Review Facility (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02592876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.

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